Malta Standards Authority Custom-Made Dental Devices Regulatory Requirements Ing. Linda-Jean Worley Consumer and Industrial Goods Directorate Malta Standards Authority MDTA Information Session 27th October, 2005

Consumer and Industrial Goods Directorate – Malta Standards Authority Background The Consumer and Industrial Goods Directorate (CIGD) of the Malta Standards Authority is the Competent Authority (CA) in Malta for medical devices. The primary role of the CA is to ensure that all medical devices sold on the Maltese market satisfy the Essential Requirements of the Directives. Consumer and Industrial Goods Directorate – Malta Standards Authority

Medical Devices Directive 93/42/EEC ~ Introduction ~ Consumer and Industrial Goods Directorate – Malta Standards Authority

Consumer and Industrial Goods Directorate – Malta Standards Authority Legislation Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (the “MDD”) has been adopted in Malta, by virtue of the Product Safety Act, Cap 427 as the Medical Devices Regulations, 2003 (L.N. 47 of 2003). The Medical Devices Regulations, 2003 have been subsequently amended by L.N. 27 of 2004, the Medical Devices (Amendment) Regulations, 2004. These regulations cover general medical devices e.g. contact lenses, dressings, pacemakers and dental devices. Consumer and Industrial Goods Directorate – Malta Standards Authority

Medical Devices Directive (MDD) Requirements Article 1 of the MDD gives the definitions and scope of the Directive. Dental devices fall within this definition and will be required to meet the requirements of the Regulations. The MDD requires devices to be classified according to a number of classification rules (Schedule IX of the Medical Devices Regulations). However, dental devices specifically made for a particular patient are classified under the regulations as “custom-made”. Consumer and Industrial Goods Directorate – Malta Standards Authority

Medical Devices Directive (MDD) Definitions (1) Manufacturer : “manufacturer” means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of these regulations to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This sub-paragraph does not apply to the person who, while not a manufacturer within the meaning of the first sub-paragraph, assembles or adapts devices already on the market to their intended purpose for an individual patient. Consumer and Industrial Goods Directorate – Malta Standards Authority

Medical Devices Directive (MDD) Definitions (2) Who is the manufacturer? In the manufacturing cycle of a “custom-made” dental device, it is considered that it is the dentist who undertakes the design of the product and the dental laboratory that manufactures it to a predefined specification. Custom-made device : “custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Consumer and Industrial Goods Directorate – Malta Standards Authority

Medical Devices Directive (MDD) Definitions (3) What is a custom-made device? A product is considered to be a “custom-made” device when it is manufactured in accordance with a qualified medical practitioner’s prescription (or by any other person authorised by virtue of his professional qualification to do so), for the sole use of a particular patient. e.g. mass produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices. (e.g. artificial teeth which are mass produced and then adapted to meet the specific requirements of the dentist are not considered as custom-made devices. Although such devices must meet the requirements of the MDD for non-custom made devices). Consumer and Industrial Goods Directorate – Malta Standards Authority

Meeting the Requirements of the Regulations Consumer and Industrial Goods Directorate – Malta Standards Authority

Summary of the main regulatory requirements Custom-made dental devices must satisfy the requirements set out in Schedule I to the regulations and shall not bear the CE marking. Before a custom-made dental device is placed on the market the manufacturer (i.e. dental laboratory) must draw up the statement of Schedule VIII to demonstrate that the device conforms to the relevant requirements of the regulations. Manufacturer must identify the link between the patient, the dentist and the dental laboratory. This must be defined for every device, together with the particular features as defined by the dentist. Manufacturer must keep a technical file available for the CA. Consumer and Industrial Goods Directorate – Malta Standards Authority

Guidance flowchart for custom-made devices manufacturers Manufacturer decision Confirm product as a medical device Meddev 2.1/1 Meddev 2.1/3 Rev2 PMS Step 7 Step 1 Confirm product as custom-medical device Incident reporting? Meddev 2.4/1 Rev8 Step 6 Step 2 Follow requested procedure Notification to CAs Draw up Schedule VIII statement Step 5 Step 3 Step 4 Step 3b – Do the risk management The prescriber is responsible for the content of the specifications. The MD manufacturer takes the responsibility and has to do the risk management for the quality of the design and manufacturing process of the CMMD according to the essential requirements and the specifications defined in the prescription. Dental technologist must analyse, evaluate and control the risks and inform the user in case of residual risks. Step 6 – Incident reporting Manufacturers of custom-made devices are requested to report any adverse incidents with custom-made devices incorporating CE-marked materials to the relevant manufacturer of the CE marked material. Step 8 – Review experience gained from Post-Market Surveillance The manufacturer shall put in place and keep updated a procedure to review experience gained from devices on the market and to implement necessary corrective action taking account of the nature and risks in relation to the product. Prepare technical documentation 3a Identify applicable requirements Do risk assessment Prepare IFU, labelling 3b 3d 3c Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 1- Confirm product as a medical device The manufacturer must confirm if the product is in compliance with the medical device definition according to its principal intended action and the means to achieve its purpose. Consult European Commission: MEDDEV 2.1/1 (Definitions of “medical devices”, “accessory” and “manufacturer); and MEDDEV 2.1/3 Rev2 (Interface with other directives – Medical devices/medicinal products). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 2 – Confirm product as custom-made medical device …refer to previous slides for definition of “custom-made” device. Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 3 – Procedures before the placing on the market Schedule I – Essential Requirements All manufacturers of custom-made dental devices must comply with Schedule I of the Medical Devices Regulations. The manufacturer of custom-made dental devices must consider the following in relation to the essential requirements set out in the regulations: Device packaging and handling (Schedule I, part 1.5) Choice of materials used, especially toxocity and compatibility between the materials and biological tissues (Schedule I, part 7.1) Elimination of the risk of infection to the patient, user and third parties and cross-infection controls (Schedule II, art 8.1) Ensure that each device is accompanied by all the information, including labelling as required by the regulations, to enable the device to be used safely (Section 13.3 of Schedule I). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 3a – Technical Documentation (1) Schedule VIII – Statement concerning devices for special purposes Schedule VIII, sections 3 & 3.1- Manufacturers of custom-made devices must keep available for the CA, documentation allowing an understanding of the design, manufacture and the expected performances of the product, so as to allow assessment of conformity with the requirements of the regulations. The manufacturer must also take the necessary measures to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned above. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 3a – Technical Documentation (2) Schedule VIII, sections 3 & 3.1 (cont.) – The technical documentation must be prepared for each group of custom-made devices under a common manufacturing procedure. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 3a – Technical Documentation (3) Must be prepared for each “group” of devices! Technical documentation : The manufacturer must be able to demonstrate that work is being carried out under controlled conditions. This will include: A documented review of the dentist’s requirements (to demonstrate an understanding of the manufacturing requirements for the design). The processing parameters must be defined together with the choice of materials used including an indication of the quality and quantity of any precious metals or non-precious metal alloys forming part of the completed device. CE marked materials should be used where there is patient contact or the manufacturer must guarantee the suitability of materials by other means; Defined manufacturing processes (e.g. work instructions); Suitability of qualified personnel; Calibration and maintenance of equipment (where appropriate); Defined handling activities and packaging requirements; A documented review of the final product, against the dentist’s initial requirements before it is supplied. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 3b – Do the risk management The prescriber (i.e. the dentist) is responsible for the content of the specifications. The MD manufacturer takes the responsibility and has to do the risk management for the quality of the design and manufacturing process of the custom-made medical device according to the essential requirements and the specifications defined in the prescription. Dental technologist must analyze, evaluate and control the risks and inform the user in case of residual risks. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 3c – Identify specific applicable requirements The manufacturer should guarantee that specific characteristics of the products are in accordance with all the applicable requirements. These specific requirements can be set out in applicable and appropriate standards and guidelines or in other European Directives. Further details can be found in the European Commission MEDDEV 2.4/1 Rev8 July 2001. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 3d – Prepare IFUs and Labelling Each device must be accompanied (according to point 13 of Schedule I) by the information needed to use it safely and to identify the manufacturer. This information comprises the label and the data in the Instructions for Use (IFUs). Minimum requirements for labelling: Name or trade name of the manufacturer; (Ref.: Schedule I.II 13.3(a)) Details strictly necessary for the professional to identify the device and the contents of the packaging (e.g. patient name/description); (Ref.: Schedule I.II 13.3(b)) The words “custom-made”; (Ref.: Schedule I.II 13.3(g)) Any special storage and/or handling conditions; (Ref.: Schedule I.II 13.3(i)) Any warnings and/or precautions to take. (Ref.: Schedule I.II 13.3(k)) Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 4 – Draw up a statement concerning custom-made devices Schedule VIII, sections 1, 2 & 2.1 – A manufacturer of a custom-made medical device must draw up the following statement for each device, containing the following information: Data allowing identification of the device in question; A statement that the device is intended for exclusive use by a particular patient, together with the name of the patient; The name of the medical practitioner or other authorised person who made out the prescription and, where applicable, the name of the clinic concerned; The particular features of the device as specified in the relevant medical prescription; and A statement that the device in question conforms to the essential requirements set out in Schedule I and, where applicable, indicating which essential requirements have not been fully met, together with the grounds. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 5 – Notify the Competent Authority (1) Regulation 10 - Registration Manufacturers of custom-made dental devices in Malta must inform the CIGD of the MSA of their registered place of business and supply the Authority with a description of the devices concerned. Before notifying, the manufacturer shall perform all activities needed to ensure that the device, which he places on the market is safe, conforms with prescription, performs as requested and meets the essential requirements of Schedule I. Must register using form CIG 201 : Medical Devices Regulations 2003 – Registration Form. On receipt of this form, the CIGD will designate a unique device registration number to each device type. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 5 – Notify the Competent Authority (2) Global Medical Device Nomenclature (GMDN): The GMDN is a collection of internationally recognised terms used to accurately describe and catalogue medical devices. The GMDN is a classification system developed to allow for the classification of all Medical Devices put onto the market as defined in the three European Directives on medical devices. The relevant GMDN code and other information (as requested by the form) for each 'device type‘ must be included. List of available GMDN codes for custom-made dental devices. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 5 – Notify the Competent Authority (3) Example on completing Part 4 of the form for custom-made metal dental crowns: 4.1. Registration type - First registration 4.2. Classification of device - Custom-made device 4.3. Device category code - 03 4.4. Device generic code – 38594 Description of device (include GMDN term) – Dental crown, custom-made, metal 4.5. Brief description of device – N/A 4.6. Is the device sterile? – No 4.7. Does the device have a measuring function? – No Also note that should the dental technologist manufacture other types of devices then he should also complete Part 4 for the other devices, as outlined above. Refer to table of available GMDN codes for custom-made dental devices. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 6 – Incident reporting Manufacturers of custom-made devices are requested to report any adverse incidents with custom-made devices incorporating CE-marked materials to the relevant manufacturer of the CE marked material. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Step 7 – Review experience gained from Post Market Surveillance (PMS) The manufacturer shall put in place and keep updated a procedure to review experience gained from devices on the market and to implement necessary corrective action taking account of the nature and risks in relation to the product. Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Responsibilities Dentist (design) Prepares prescription Review prescription and documents any changes made after discussions with the dentist Manufactures under controlled condition as per Schedule I Review technical file document which may be carried out via audit Issues registration number for reference Register Laboratories Dental Device accepted by Dentist Issue device to Dentist with statement as per Schedule VIII, section 1, 2 and 2.1 May request lot numbers of custom made device to be made available Dental Laboratory (Manufacture) MSA-CIGD (CA) Final Inspection Packages and labels as per Schedule I.1, section 13.3 Step 6 – Incident reporting Manufacturers of custom-made devices are requested to report any adverse incidents with custom-made devices incorporating CE-marked materials to the relevant manufacturer of the CE marked material. Step 8 – Review experience gained from Post-Market Surveillance The manufacturer shall put in place and keep updated a procedure to review experience gained from devices on the market and to implement necessary corrective action taking account of the nature and risks in relation to the product. Consumer and Industrial Goods Directorate – Malta Standards Authority

Sources of information Guideline for classification: “Guideline for the classification of medical devices”, MEDDEV 2.4/1, Rev 8, July 2001. Guideline for the definitions of “medical devices”, “accessory” and “manufacturer”: “Guidelines related to the application of: the Council Directive 90/385/EEC on Active Implantable Medical Devices, the Council Directive 93/42/EEC on Medical Devices”, MEDDEV 2.1/1 April 1994. User guide for GMDN: http://www.gmdn.org/GMDN_Technical_2003v2.pdf Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

Consumer and Industrial Goods Directorate – Malta Standards Authority Useful websites European Commission’s website: http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm MSA website: http://www.msa.org.mt GMDN: http://www.gmdn.org/index.xalter Note: For devices of Class IIa, IIb and III statement must accompany the device back to the prescriber. (Regulation 5.4, second indent). Consumer and Industrial Goods Directorate – Malta Standards Authority

THANK YOU www.msa.org.mt For further information, please contact: CE Marking in Maltese Legislation Thursday April 21, 1999 For further information, please contact: Ing. Linda-Jean Worley Consumer and Industrial Goods Directorate Malta Standards Authority 2nd. Floor, Evans Building, Merchants Street, Valletta. Tel: (00356) 21242420; Fax: (00356) 21242406; e-mail: anthony.camilleri@msa.org.mt THANK YOU Thank you. Visit the MSA website at … www.msa.org.mt Ing.A.Camilleri, Technical Co-ordinator (Engineering) 30